VentriClear Ventricular Drainage Catheter Set — Class II medical device recall Z-2791-2018
Terminated recall by Cook Inc., reported 2018-08-22, distributed in IN. This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging fr
| Recall number | Z-2791-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2018-05-31 |
| Classified | 2018-08-11 |
| Reported by FDA | 2018-08-22 |
| Terminated | 2019-04-11 |
| Distributed | IN |
| Quantity | 250 |
| Reason classes | sterility |
| Lot numbers | 8639185 |
| Model numbers | N-VVDC-01-ABRM |
Product
VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.
Reason for recall
This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflammatory response syndrome (SIRS).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2791-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.